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510(k) K201458

Scrambler Therapy Technology (Model ST-5A) by Delta International Services & Logistics S.R.L — Product Code GZJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2020
Date Received
June 1, 2020
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
Device Class
Class II
Regulation Number
882.5890
Review Panel
NE
Submission Type

Other clearances by Delta International Services & Logistics S.R.L

  • K142666 — Scrambler Therapy MC-5 A Device (May 22, 2015)

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